Curiteva has achieved a significant regulatory milestone with FDA 510(k) clearance for its Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System, representing the world's first 3D printed, fully interconnected porous PEEK structure for spinal fusion procedures. The Huntsville, Alabama-based technology manufacturer announced the clearance for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures.
Revolutionary 3D Printing Technology
The Inspire platform is manufactured using Curiteva's proprietary, patented Fused Filament Fabrication 3D printer, which was designed, programmed, and built entirely by the company. This groundbreaking additive process produces a fully interconnected and integrated trabecular PEEK lattice structure that traverses the entire implant to promote osseointegration, improve radiographic assessment, and deliver superior biomechanics.
"In addition to our proprietary printing operation, we have assembled an FDA Master File and implemented rigorous quality and process controls which demonstrates the process performance is extremely capable," emphasized Chad Falciani, Founder and Chairman of Curiteva.
The unique architecture creates a PEEK structure with superior biomechanical strength compared to traditional PEEK implants. The combination of the novel trabecular PEEK structure with the patented HAFUSE nano-texturing creates a hydrophilic, bioactive environment for cell attachment, proliferation, and healing, as demonstrated in pre-clinical animal and in vitro studies.
Rapid Regulatory Success
The comprehensive 510(k) review process took less than 60 days from submission to clearance, achieved through collaboration with MCRA, a leading medical device Clinical Research Organization. Justin Eggleton, Vice President and Head of Musculoskeletal Regulatory Affairs at MCRA, noted that "this innovative device combines the latest in 3D printing, biomaterial science, and engineering excellence that will offer improved surgical solutions for this patient population."
Eric Linder, Curiteva's Chief Technology Officer and Founder, commented on the partnership: "Working with MCRA as a strategic partner to advance our regulatory portfolio utilizing our transformative porous PEEK technology was critical in the rapid achievement of our recent FDA 510(k) clearance."
Building on Clinical Success
This marks Curiteva's second FDA-cleared 3D printed PEEK implant with HAFUSE technology, following the approval of the Inspire Trabecular PEEK Cervical Interbody Fusion System in February 2023. The cervical system represented the industry's first 3D printed PEEK device to receive regulatory clearance and has achieved over 1,000 successful implantations in more than 500 patients since its April 2023 launch.
"Reported patient outcomes for Inspire cervical in the first 9 months reinforce our pre-clinical observations and we plan to publish those results later this year," commented CEO Mike English.
Commercial Readiness and Manufacturing Scale
Curiteva has demonstrated significant manufacturing capabilities, with over 7,000 implants now commercially available in inventory. Falciani noted that "advancements in PEEK over the last decade were cost-prohibitive and operationally challenging to scale. Our experience and commitment to lean operational efficiency allowed us to accelerate our proprietary print operation."
The company plans a commercial introduction of the Inspire system for TLIF (transforaminal lumbar interbody fusion) and PLIF (posterior lumbar interbody fusion) procedures in Q2 of 2024.
Future Development Pipeline
Curiteva continues to expand its spine portfolio products leveraging the proprietary trabecular PEEK technology. English acknowledged the company's strategic partnerships: "We are thankful for our partners at MCRA, Empirical, Promimic, and Evonik for their extraordinary support on this regulatory path we are forging to advance additive PEEK manufacturing to improve patient healing and outcomes in the spine and MSK space."
